The FDA just issued a press release describing problems with TNF Blockers. TNF blockers have been approved for treatment of immune system diseases, including juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ankylosing spondylitis.
The problems are severe—these drugs may cause an increased risk of lymphoma, leukemia and other cancers, particularly in children. The FDA first disclosed problems in a June 4, 2008 communication, based on about 30 reports of cancer in children. The updated FDA analysis leading to this week’s warning is based on a review of 48 cases of malignancies, including 11 deaths. The FDA also had reports of 147 cases of leukemia in children and adults, including 30 deaths. It is still unclear how strong the association is, because there is a small population of children on TNF blockers, and those children are typically concurrently prescribed other immunosuppressive therapies.
Exmples of these TNF blockers include:
- Simponi (golimumab) by Johnson & Johnson
- Remicade (infliximab) by Johnson & Johnson
- Humira (adalimumab) by Humira
- Cimzia (certolizumab pegol) by UCB SA
- Enbrel (etanercept) by Amgen Inc. and Wyeth
We expect that lawsuits will be coming in, though there remains much work to be done on the science end. Hopefully there aren’t many children who have been affected by these drugs.